Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - flucelvax

Document Subject

Generated Narrative: MedicinalProductDefinition mp56a32a5ee239fc834b47c10db1faa3fd

identifier: http://ema.europa.eu/identifier/EU/1/18/1326/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Flucelvax Tetra suspension for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-56a32a5ee239fc834b47c10db1faa3fd

identifier: http://ema.europa.eu/identifier/EU/1/18/1326/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - flucelvax

Attesters

What is in this leaflet

1. What Flucelvax Tetra is and what it is used for
2. What you need to know before you receive Flucelvax Tetra
3. How Flucelvax Tetra is given
4. Possible side effects
5. How to store Flucelvax Tetra
6. Contents of the pack and other information

Flucelvax Tetra is a vaccine against flu (influenza). Flucelvax Tetra is prepared in cell cultures, and, therefore, is egg-free. When a person is given the vaccine, the immune system (the body s natural defence system) will produce its own protection against the influenza virus. None of the ingredients in the vaccine can cause flu.

Flucelvax Tetra is used to prevent flu in adults and children from 2 years of age.

The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2023/2024 SEASON.

You should not receive Flucelvax Tetra: If you are allergic to:

• the active ingredients or any of the other ingredients of this medicine (listed in section 6)
• beta-propiolactone, cetyltrimethylammonium bromide, or polysorbate 80, which are trace residues from the manufacturing process.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before receiving Flucelvax Tetra.

BEFORE receiving the vaccine

• Your doctor or nurse will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration. This reaction may occur with Flucelvax Tetra as with all vaccines that are injected.

• You should tell your doctor if you have an acute illness associated with fever. Your doctor may decide to delay your vaccination until your fever is gone.

• You should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see section Other medicines and Flucelvax Tetra ).

• You should tell your doctor if you have a bleeding problem or bruise easily.

• Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you fainted with a previous injection.

As with all vaccines, Flucelvax Tetra may not fully protect all persons who are vaccinated.

Children aged less than 2 years This vaccine is currently not recommended in children aged less than 2 years as safety and efficacy in this age group have not been established.

Other medicines and Flucelvax Tetra
Tell your doctor or nurse if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription or if you have recently received any other vaccine.

Flucelvax Tetra may be given at the same time as other vaccines.

Pregnancy and breast-feeding
Pregnancy Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. Influenza vaccines may be given in any trimester of pregnancy.

Breast-feeding Use of Flucelvax Tetra during breast-feeding has not been studied. No effects on breast fed babies are expected. Flucelvax Tetra may be given during breast-feeding.

Driving and using machines Flucelvax Tetra has no or negligible effect on your ability to drive and use machines.

Flucelvax Tetra contains sodium chloride and potassium chloride This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free . This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially potassium-free .

Flucelvax Tetra is given to you by your doctor or nurse as an injection into the muscle at the top of the upper arm (deltoid muscle) or into the muscle of the upper and outer part of the thigh in young children depending on the muscle size.

Adults and children from 2 years of age:

One dose of 0.5 ml

If your child is younger than 9 years of age and has not been previously vaccinated against flu, a second dose should be given after at least 4 weeks.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported during clinical studies and during general use:

Very serious side effects Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect you may need urgent medical attention or hospitalisation:

Difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction)

Serious side effects Tell your doctor immediately if you experience any of the following side effects you may need medical attention:

You feel weak, you have difficulty moving around or you experience numbness or tingling in your limbs. These can be symptoms of Guillain-Barr syndrome (GBS), an autoimmune disease caused by your body s own immune system. Extensive swelling of injected limb

Other side effects Very common (may affect more than 1 in 10 people) Injection site pain, bruising, reddening and hardening or swelling at the site of the injection Headache Muscle pain
Tiredness
Loss of appetite Irritability (only reported in children from 2 to < 6 years) Sleepiness (only reported in children 2 to < 6 years) Hardening or swelling at the site of the injection, headache, muscle pain, and tiredness were common in the elderly. Bruising at the site of the injection was common in adults, eldery and children 9 to < 18 years. Headache was common in the elderly. Loss of appetite was common in adults, eldery and children 9 to < 18 years.

Common (may affect up to 1 in 10 people) Nausea, vomiting, diarrhoea
Joint pain Shivering Change in eating habits (only reported in children from 2 to < 6 years) Fever (> 38 C) Vomiting was uncommon in the elderly. Fever was uncommon in adults and the elderly.

Not known (frequency cannot be estimated from the available data) Numbness and tingling sensation (paraesthesia) Generalised skin reactions including itching, bumps on the skin (pruritis, urticaria) or non-specific rash

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this vaccine out of the sight and reach of children.

Do not use this vaccine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C to 8 C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light.

.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Flucelvax Tetra contains

The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:

A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/Georgia/12/2022 CVR-167) 15 micrograms HA** A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) 15 micrograms HA** B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) 15 micrograms HA** B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type) 15 micrograms HA**

per 0.5 ml dose . * propagated in Madin Darby Canine Kidney (MDCK) cells (this is the special cell culture in which the influenza virus is grown);
** haemagglutinin

This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2023/2024 SEASON.

The other ingredients are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections. (see Section 2 Flucelvax Tetra contains sodium and potassium)

What Flucelvax Tetra looks like and contents of the pack

Flucelvax Tetra is a suspension for injection (injection) in a pre-filled syringe (ready to use syringe).
Flucelvax Tetra is a clear to slightly opalescent suspension. A single syringe contains 0.5 ml of suspension for injection. Flucelvax Tetra is available in packs containing 1 pre-filled syringe with or without needle or 10 pre- filled syringes with or without needles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Seqirus Netherlands B.V. Paasheuvelweg 1105BJ Amsterdam Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Lietuva

Seqirus Netherlands B.V.Nederland/Netherlands Tel: +31 (0) 20 204 6
Seqirus Netherlands B.V.
.: +31 (0) 20 204 6 esk republika Seqirus Netherlands B.V. Nizozemsko Tel: +31 (0) 20 204 6Danmark Seqirus Netherlands B.V. Holland Tlf: +31 (0) 20 204 6Deutschland Seqirus GmbH Marburg Tel: 08003601Eesti Seqirus Netherlands B.V. Holland Tel: +31 (0) 20 204 6
WIN MEDICA . . : 210 7488Espa a Seqirus Spain, S.L., Barcelona Tel: 937 817 France Seqirus Netherlands B.V. Netherlands T l: +31 (0) 20 204 6Hrvatska Seqirus Netherlands B.V. Nizozemska Tel: +31 (0) 20 204 6Ireland Seqirus UK Limited Maidenhead Tel: +44 1628 641 sland Seqirus Netherlands B.V. Holland S mi: +31 (0) 20 204 6Italia Seqirus S.r.l. Siena Tel: +39 0577 096
Seqirus Netherlands B.V.
: +31 (0) 20 204 6Latvija Seqirus Netherlands B.V. Nyderlandai Tel: +31 (0) 20 204 6Luxembourg/Luxemburg Seqirus Netherlands B.V. Netherlands T l/Tel: +31 (0) 20 204 6Magyarorsz g Seqirus Netherlands B.V. Hollandia Tel.: +31 (0) 20 204 6Malta Seqirus Netherlands B.V. In-Netherlands Tel: +31 (0) 20 204 6Nederland Seqirus Netherlands B.V. Amsterdam Tel: +31 (0) 20 204 6Norge Seqirus Netherlands B.V. Nederland Tlf: +31 (0) 20 204 6 sterreich Valneva Austria GmbH, Wien Tel: +43 1 20620 2Polska Seqirus Netherlands B.V. Holandia Tel.: +31 (0) 20 204 6Portugal Seqirus Netherlands B.V. Pa ses Baixos Tel: +31 (0) 20 204 6Rom nia Seqirus Netherlands B.V. Olanda Tel: +31 (0) 20 204 6Slovenija Seqirus Netherlands B.V. Nizozemska Tel: +31 (0) 20 204 6Slovensk republika Seqirus Netherlands B.V. Holandsko Tel: +31 (0) 20 204 6Suomi/Finland Seqirus Netherlands B.V. Alankomaat Puh/Tel: +31 (0) 20 204 6Sverige Seqirus Netherlands B.V. Nederl nderna Tel: +31 (0) 20 204 6Seqirus Netherlands B.V. N derlande Tel: +31 (0) 20 204 6This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: